Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202310674176154 Date of Approval: 06/10/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Mobile Health Technology in HIV Adolescents Care Trial
Official scientific title Assessing the Effectiveness of Introducing Mobile Health Technology into the HIV Program to Enhance Care Amongst Adolescents and Young Adults living in Fako Division
Brief summary describing the background and objectives of the trial In the fight to achieve epidemic control and lessen the burden of the pandemic on the future generation countries need to seek innovative ways to achieve the 95-95-95 target by 2030. Introducing mobile health technology in HIV care will enhance privacy, give clients faster access to providers, and care especially for the adolescents and young adults who fear stigmatization. For this study, we seek to develop a mobile health application to facilitate service delivery for HIV clients. The aim of this study is to assess the efficiency of Introducing Mobile Health Technology into the HIV Program to enhance care among adolescents and young adults in Fako Division of the South West Region, of Cameroon
Type of trial Non-Randomised
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Treatment follow up
Anticipated trial start date 01/09/2023
Actual trial start date
Anticipated date of last follow up 31/03/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 126
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Single Group Non-randomised Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Standard care Daily pill reminders 6months Routine adherence counselling and reminders will be send to the participants to influence their health seeking behavioral and adherence 129
Experimental Group Standard care Daily pill reminders 6months Routine adherence counselling and reminders will be send to the participants to influence their health seeking behavioral and adherence 129
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Aged 15 to 24 years, 2. owned a smart mobile phone, 3. willing to install the App before the start date of the study, 4. Be able to read text messages. 1. We shall exclude participants who have been on HAART for less than a year 2. Participants below 15years of age Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 15 Year(s) 24 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 27/03/2023 Faculty of Health Sciences Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
Faculty of Health Sciences, University of Buea, P.O Box 12 Buea 00237 Cameroon
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Retention in care Baseline Three months and Six months
Primary Outcome Adherence Baseline Three months and Six months
Primary Outcome Virologic suppression Baseline Three months and Six months
Secondary Outcome Number of visit appointment date respected Baseline Three months and Six months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Limbe Regional Hospital HIV Treatment Centre Mile 1 Limbe Cameroon
Buea Regional Hospital Buea Buea Cameroon
Muyuka District Hospital Buea-Kumba Road Muyuka Cameroon
Muyuka District Hospital Tiko Tiko Cameroon
FUNDING SOURCES
Name of source Street address City Postal code Country
Charles Njumkeng Faculty of Health Sciences, University of Buea, P.O Box 12 Buea 00237 Cameroon
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Charles Njumkeng Faculty of Health Sciences, University of Buea, P.O Box 12 Buea 00237 Cameroon Individual
COLLABORATORS
Name Street address City Postal code Country
Njukeng A. Patrick Faculty of Sciences, University of Buea, P.O Box 63 Buea 00237 Cameroon
Egbe Thomas O Faculty of Health Sciences, University of Buea, P.O Box 12 Buea 00237 Cameroon
Tendongfor Nicholas Faculty of Health Sciences, University of Buea, P.O Box 12 Buea 00237 Cameroon
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Charles Njumkeng njumkengcharly@gmail.com +237674083627 Faculty of Health Sciences, University of Buea, P.O Box 12
City Postal code Country Position/Affiliation
Buea 00237 Cameroon Student
Role Name Email Phone Street address
Public Enquiries Charles Njumkeng njumkengcharly@gmail.com +237674083627 Faculty of Health Sciences, University of Buea, P.O Box 12
City Postal code Country Position/Affiliation
Buea 00237 Cameroon Student of PhD
Role Name Email Phone Street address
Scientific Enquiries Patrick A. Njukeng pachiangia@ghsscm.org +237674083627 Faculty of Sciences, University of Buea, P.O Box 63
City Postal code Country Position/Affiliation
Buea 00237 Cameroon Vice Dean
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual Participant Data (IPD) will not be shared We do not plan to share the data because we are working with the adolescent population living with HIV many of whom were just disclosed. The management of the disclosure status makes it difficult to obtain consent information from their guidance to share data. Study Protocol This is not applicable as Individual Participant Data (IPD) will not be shared This is not applicable
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Public title 05/10/2023 Response to review comment Mobile Health Technology in HIV Adolescents Care Trail Mobile Health Technology in HIV Adolescents Care Trial
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Official scientific title 05/10/2023 spelling error Assessing the Feasibility of Introducing Mobile Health Technology into the HIV Program to Enhance Care Amongst Adolescents and Young Adults living in Fako Division Assessing the Effectiveness of Introducing Mobile Health Technology into the HIV Program to Enhance Care Amongst Adolescents and Young Adults living in Fako Division
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Inclusion criteria 28/08/2023 Responding to Review Comments Aged 15 to 24 years, owned a smart mobile phone, willing to install the App before the start date of the study, be able to read text messages. 1. Aged 15 to 24 years, 2. owned a smart mobile phone, 3. willing to install the App before the start date of the study, 4. Be able to read text messages.
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Exclusion criteria 28/08/2023 Responding to Review Comments We shall exclude participants who have been on HAART for less than a month and aged less than 15years. 1. We shall exclude participants who have been on HAART for less than a month 2. Participants below 15years of age
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Exclusion criteria 31/03/2025 To indicated the exact criteria used for the study 1. We shall exclude participants who have been on HAART for less than a month 2. Participants below 15years of age 1. We shall exclude participants who have been on HAART for less than a year 2. Participants below 15years of age
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 31/03/2025 To indicate the actual number that was recruited Experimental Group, Standard care, Daily pill reminders , 6months, Routine adherence counselling and reminders will be send to the participants to influence their health seeking behavioral and adherence , 126, Experimental Group, Standard care, Daily pill reminders , 6months, Routine adherence counselling and reminders will be send to the participants to influence their health seeking behavioral and adherence , 129,
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 05/10/2023 Added ethical Clearance FALSE, Faculty of Health Sciences Institutional Review Board, Faculty of Health Sciences, University of Buea, P.O Box 12, Buea, 00237, Cameroon, 14 Mar 2023, , +237678518960, fhsirb@gmail.com, TRUE, Faculty of Health Sciences Institutional Review Board, Faculty of Health Sciences, University of Buea, P.O Box 12, Buea, 00237, Cameroon, 14 Mar 2023, 27 Mar 2023, +237678518960, fhsirb@gmail.com, 25785_24703_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 31/03/2025 Added ethical Clearance TRUE, Faculty of Health Sciences Institutional Review Board, Faculty of Health Sciences, University of Buea, P.O Box 12, Buea, 00237, Cameroon, , 27 Mar 2023, +237678518960, fhsirb@gmail.com, 25785_24703_4737.pdf TRUE, Faculty of Health Sciences Institutional Review Board, Faculty of Health Sciences, University of Buea, P.O Box 12, Buea, 00237, Cameroon, , 27 Mar 2023, +237678518960, fhsirb@gmail.com, 25785_24703_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 28/08/2023 Responding to review comments Individual Participant Data (IPD) will not be shared Individual Participant Data (IPD) will not be shared We do not plan to share the data beciuase we are working with the adolescent population living with HIV many of whom were just disclosed. The management of the disclosure status makes it difficult to obtain consent information from their guidance to share data.
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 05/10/2023 corrected spelling error Individual Participant Data (IPD) will not be shared We do not plan to share the data beciuase we are working with the adolescent population living with HIV many of whom were just disclosed. The management of the disclosure status makes it difficult to obtain consent information from their guidance to share data. Individual Participant Data (IPD) will not be shared We do not plan to share the data because we are working with the adolescent population living with HIV many of whom were just disclosed. The management of the disclosure status makes it difficult to obtain consent information from their guidance to share data.
Section Name Field Name Date Reason Old Value Updated Value
Reporting Key access criteria 31/03/2025 To make it read better None Applicable This is not applicable